Acupuncture for Breast Engorgement During Lactation

August 1, 2017 updated by: PeiJung Chiang, Taichung Veterans General Hospital

Acupuncture for Breast Engorgement During Lactation: a Pilot Study.

Breast engorgement which may manifest swell, throb, and cause mild to extreme pain is the common difficulty for breast feeding woman. It occurs in the mammary glands due to expansion and pressure exerted by the synthesis and storage of breast milk and it usually happens when the breasts switch from colostrums to mature milk. However, engorgement can also happen if lactating women miss several nursing and not enough milk is expressed from the breasts. It can be exacerbated by insufficient breastfeeding and/or blocked milk ducts. Engorgement may lead to mastitis and untreated engorgement puts pressure on the milk ducts, often causing a plugged duct.

According the meridian theory, the investigators propose the acupuncture treatment for patients of breast engorgement.

The investigators will include 60 patients and measure the acupuncture effect. The inclusion criteria are women with breast engorgement and 20 years old or older. Exclusion standards are patients with: 1. diabetes mellitus 2. Psychological disease or mental illness 3. Fever > 38 degrees Celsius 4. Mastitis 5.analgetics or anti - inflammatory agents used 6. ultrasound therapy applied

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 407
        • Not yet recruiting
        • Taichung Veterans General Hospital
        • Contact:
      • Taichung, Taiwan, 407
        • Recruiting
        • TCM
        • Contact:
          • PeiJung Chiang
          • Phone Number: 886963826707

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women with breast engorgement and 20 years old or older

Exclusion Criteria:

  • patients with:

    1. diabetes mellitus
    2. psychological disease or mental illness
    3. Fever > 38 degrees Celsius
    4. Mastitis
    5. analgesics or anti - inflammatory agents used
    6. ultrasound therapy applied

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment
Device: acupuncture
Device: acupuncture Acupuncture is the treatment which balances qi and blood by inserting needles into the acupoints of the meridians in human body.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
breast engorgement
Time Frame: 3 days
Six-point Engorgement Scale
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mastitis
Time Frame: 3 days
The incidence of mastitis
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Investigators

  • Principal Investigator: PeiJung Chiang, Traditional Chinese Medicine Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2017

Primary Completion (Anticipated)

June 26, 2018

Study Completion (Anticipated)

June 26, 2018

Study Registration Dates

First Submitted

July 24, 2017

First Submitted That Met QC Criteria

July 25, 2017

First Posted (Actual)

July 26, 2017

Study Record Updates

Last Update Posted (Actual)

August 2, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CF17141A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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